Yuan Hang, Li Zhen, Cao Guang-Shao, Xu Fei, Wu Gang, Ding Peng-Xu, Wei Qiu-Liang, Chang Zu-Kuan, Xing Cheng, Niu Huan-Zhang, Yin Jun, Yao Quan-Jun, Zheng Lin, Xiao Jin-Cheng, Chen Cheng-Shi, Cheng Hong-Tao, Zong Deng-Wei, Xia Wei-Li, Geng Xiang, Zhao Xiao-Hui, Li Hai-Liang, Hu Hong-Tao
Department of Interventional Radiology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Front Oncol. 2025 Jul 3;15:1615911. doi: 10.3389/fonc.2025.1615911. eCollection 2025.
To analyze the efficacy and safety of transarterial chemoembolization (TACE) with apatinib (TACE-A) for the treatment of advanced hepatocellular carcinoma (HCC).
Data from advanced HCC patients treated with TACE-A between January 2019 and June 2022 were evaluated. The patients from 8 medical centers were included. The primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoints were objective response rate (ORR) and adverse events (AEs). Prognostic factors affecting OS were analyzed, and the tumor imaging response at the first follow-up was evaluated to study the survival differences among patients.
A total of 389 patients were included, the median PFS was 7.0 months (95% confidence interval [CI]: 6.3-7.7), and the median OS (mOS) was 18.9 months (95% CI: 17.5-20.3). The median time of the first follow-up was 1.2 months, the ORR was 33.7%, and the mOS of the complete response, partial response, stable disease, and progressive disease groups were 30.1, 20.9, 18.5, and 12.9 months, respectively. The difference was statistically significant ( < 0.05). Univariate and multivariate Cox regression analyses demonstrated that the prognostic factors affecting OS were distant metastasis, maximum tumor diameter, TACE duration, and alpha-fetoprotein (AFP) level ( < 0.05). The overall incidence of grade 3 and above AEs was 18.0% (70/389), and the overall safety was controllable.
TACE-A significantly improved OS, PFS, and ORR in advanced HCC patients. At the first follow-up patients with a poor tumor response had a poor prognosis. Distant metastasis, maximum tumor diameter, TACE frequency, and AFP levels are important prognostic factors that affect OS in patients. AEs of combination therapy are safe and manageable.
Chinese Clinical Trials Database (ChiCTR1900024030).
分析阿帕替尼经动脉化疗栓塞术（TACE-A）治疗晚期肝细胞癌（HCC）的疗效和安全性。
评估2019年1月至2022年6月期间接受TACE-A治疗的晚期HCC患者的数据。纳入了来自8个医学中心的患者。主要终点为总生存期（OS）和无进展生存期（PFS）。次要终点为客观缓解率（ORR）和不良事件（AE）。分析影响OS的预后因素，并评估首次随访时的肿瘤影像反应，以研究患者之间的生存差异。
共纳入389例患者，中位PFS为7.0个月（95%置信区间[CI]：6.3-7.7），中位OS（mOS）为18.9个月（95%CI：17.5-20.3）。首次随访的中位时间为1.2个月，ORR为33.7%，完全缓解、部分缓解、疾病稳定和疾病进展组的mOS分别为30.1、20.9、18.5和12.9个月。差异具有统计学意义（<0.05）。单因素和多因素Cox回归分析表明，影响OS的预后因素为远处转移、最大肿瘤直径、TACE持续时间和甲胎蛋白（AFP）水平（<0.05）。3级及以上AE的总发生率为18.0%（70/389），总体安全性可控。
TACE-A显著改善了晚期HCC患者的OS、PFS和ORR。在首次随访时，肿瘤反应差的患者预后不良。远处转移、最大肿瘤直径、TACE频率和AFP水平是影响患者OS的重要预后因素。联合治疗的AE安全且可控。
中国临床试验数据库（ChiCTR1900024030）
